-
2
-
-
0001754584
-
Experimental methods used in determining chronic toxicity: Critical review
-
Barnes, J. M. and Denz, F. A. (1954) Experimental methods used in determining chronic toxicity: critical review. Pharmacological Reviews 6, 191-242.
-
(1954)
Pharmacological Reviews
, vol.6
, pp. 191-242
-
-
Barnes, J.M.1
Denz, F.A.2
-
3
-
-
0022410729
-
Is the clinical trial evidence about new drugs statistically adequate?
-
Bland, J. M., Jones, D. R., Bennett, S., Cook, D. G., Haines, A. P. and MacFarlane, A. J. (1985) Is the clinical trial evidence about new drugs statistically adequate? British Journal of Clinical Pharmacology 19, 155-160.
-
(1985)
British Journal of Clinical Pharmacology
, vol.19
, pp. 155-160
-
-
Bland, J.M.1
Jones, D.R.2
Bennett, S.3
Cook, D.G.4
Haines, A.P.5
MacFarlane, A.J.6
-
6
-
-
26844486333
-
U.S. Drug safety regime "flawed"
-
9 November
-
Day, M. (1996) U.S. drug safety regime "flawed". New Scientist 9 November, 10.
-
(1996)
New Scientist
, pp. 10
-
-
Day, M.1
-
19
-
-
0010742566
-
-
20 July
-
FDA (1976f) Naproxen. Memo by F. Kelsey, 20 July.
-
(1976)
Naproxen
-
-
Kelsey, F.1
-
21
-
-
0010702990
-
-
Memo, 30 August
-
FDA (1976 h) Syntex-naprosyn. Memo, 30 August.
-
(1976)
Syntex-naprosyn
-
-
-
28
-
-
0010748650
-
-
Memo by M. J. Finkel, Associate Director for New Drug Evaluation, 23 October
-
FDA (1979 d) Memo by M. J. Finkel, Associate Director for New Drug Evaluation, 23 October.
-
(1979)
-
-
-
32
-
-
0010661937
-
-
Memo of meeting between McNeil Laboratories and FDA, 16 October
-
FDA (1980 d) Memo of meeting between McNeil Laboratories and FDA, 16 October.
-
(1980)
-
-
-
33
-
-
0010662780
-
-
Memo by M. J. Finkel, Associate Director of New Drug Evaluation, 7 October
-
FDA (1980e) Memo by M. J. Finkel, Associate Director of New Drug Evaluation, 7 October.
-
(1980)
-
-
-
35
-
-
0010742567
-
-
Addendum by D. J. Richman to FDA supplementary pharmacology review by M. Hein, 7 July
-
FDA (1980 g) Addendum by D. J. Richman to FDA supplementary pharmacology review by M. Hein, 7 July.
-
(1980)
-
-
-
36
-
-
0010657015
-
-
Certified letter of non-approval of the benoxaprofen NDA by Marion Finkel, 25 February
-
FDA (1981a) Certified letter of non-approval of the benoxaprofen NDA by Marion Finkel, 25 February.
-
(1981)
-
-
-
37
-
-
0010700267
-
-
Memo of meeting between McNeil Laboratories and FDA, 23 November
-
FDA (1981b) Memo of meeting between McNeil Laboratories and FDA, 23 November.
-
(1981)
-
-
-
39
-
-
0010745981
-
-
Certified letter to Lilly of approval for benoxaprofen by Finkel, April 19
-
FDA (1982b) Certified letter to Lilly of approval for benoxaprofen by Finkel, April 19.
-
(1982)
-
-
-
40
-
-
0010742785
-
-
Memo of meeting with McNeil, 5 February
-
FDA (1982c) Adrenal tumour and combinations. Memo of meeting with McNeil, 5 February.
-
(1982)
Adrenal Tumour and Combinations
-
-
-
41
-
-
0010702051
-
-
Memo of meeting with Lilly, 21 December
-
FDA (1983a) Memo of meeting with Lilly, 21 December.
-
(1983)
-
-
-
43
-
-
0010751204
-
-
Memo of meeting with McNeil, 4 March
-
FDA (1983c) Memo of meeting with McNeil, 4 March.
-
(1983)
-
-
-
45
-
-
0010708454
-
-
Memo of meeting between J. Harter and D. Pease of the FDA with Max Talbott of Lilly, 18 July
-
FDA (1985a) Memo of meeting between J. Harter and D. Pease of the FDA with Max Talbott of Lilly, 18 July.
-
(1985)
-
-
-
48
-
-
0010703225
-
-
Addendum by D. J. Richman to FDA review and evaluation of pharmacology and toxicology data by C. Chen, 18 July
-
FDA (1985 d) Addendum by D. J. Richman to FDA review and evaluation of pharmacology and toxicology data by C. Chen, 18 July.
-
(1985)
-
-
-
49
-
-
0010665944
-
-
Group leader summary by J. Harter, 25 June
-
FDA (1985e) Group leader summary by J. Harter, 25 June.
-
(1985)
-
-
-
50
-
-
0010666753
-
-
Memo of meeting with McNeil and Ortho, 25 November
-
FDA (1985f) Memo of meeting with McNeil and Ortho, 25 November.
-
(1985)
-
-
-
51
-
-
0010664020
-
-
19 August
-
FDA Arthritis Advisory Committee (1983) Discussion of Zomax, 19 August.
-
(1983)
Discussion of Zomax
-
-
-
53
-
-
0018763674
-
Scientific basis for identification of potential carcinogens and estimation of risks
-
Interagency Regulatory Liason Group (IRLG)(1979) Scientific basis for identification of potential carcinogens and estimation of risks. .Journal of the National Cancer Institute 63, 241-268.
-
(1979)
Journal of the National Cancer Institute
, vol.63
, pp. 241-268
-
-
-
54
-
-
0010660649
-
The status of S1B (carcinogenicity guidelines)
-
ICH, Yokohama, Japan
-
International Conference on Harmonisation of Technical Standards for Medicinal Products (ICH) (1995) The status of S1B (carcinogenicity guidelines). In ICH3 Closing Report, Status of Harmonisation, ICH, Yokohama, Japan.
-
(1995)
ICH3 Closing Report, Status of Harmonisation
-
-
-
55
-
-
0018130755
-
Chemical carcinogens: The scientific basis for regulation
-
Maugh, T. H. (1978) Chemical carcinogens: the scientific basis for regulation. Science 201, 1200-1205.
-
(1978)
Science
, vol.201
, pp. 1200-1205
-
-
Maugh, T.H.1
-
59
-
-
0010704018
-
-
April
-
Ortho-Cilag (1981) Zomax data sheet, April.
-
(1981)
Zomax Data Sheet
-
-
-
60
-
-
0010666754
-
-
ABPI Compendia
-
Ortho-Cilag (1984) Suprol data sheets, ABPI Compendia.
-
(1984)
Suprol Data Sheets
-
-
-
61
-
-
0010751205
-
-
Personal communication Telephone interview with Dr Berridge, preclinical assessor at the Medicines Control Agency, Department of Health, U.K., November
-
Personal communication (1995a) Telephone interview with Dr Berridge, preclinical assessor at the Medicines Control Agency, Department of Health, U.K., November.
-
(1995)
-
-
-
62
-
-
0010700268
-
-
Personal communication Interview with Dr Schmidt at BfArM, the German drug regulatory authorities, November
-
Personal communication (1995b) Interview with Dr Schmidt at BfArM, the German drug regulatory authorities, November.
-
(1995)
-
-
-
63
-
-
0010708818
-
-
Personal interview Dr Kerausitis, FDA Medical Officer, 3 November
-
Personal interview (1988) Dr Kerausitis, FDA Medical Officer, 3 November.
-
(1988)
-
-
-
65
-
-
77957178396
-
The lifetime feeding study in mice and rats - An examination of its validity as a bioassay for human carcinogens
-
Salsburg, D. (1983) The lifetime feeding study in mice and rats - an examination of its validity as a bioassay for human carcinogens. Fundamental and Applied Toxicology 3, 63-67.
-
(1983)
Fundamental and Applied Toxicology
, vol.3
, pp. 63-67
-
-
Salsburg, D.1
-
70
-
-
0010657017
-
Hearings before the subcommittee on health and scientific research of the senate committee on human resources
-
10 March. U.S. Congress, Washington, DC
-
U.S. Congress (1977) Hearings before the Subcommittee on Health and Scientific Research of the Senate Committee on Human Resources. In Preclinical and Clinical Testing by the Pharmaceutical Industry, 1977, Part IV, 10 March. U.S. Congress, Washington, DC.
-
(1977)
Preclinical and Clinical Testing by the Pharmaceutical Industry, 1977, Part IV
-
-
-
71
-
-
0010657018
-
Hearings before a subcommittee of the committee on government operations house of representatives 97th congress
-
3-4 August. U.S.G.P.O., Washington, DC
-
U.S. Congress (1982) Hearings before a Subcommittee of the Committee on Government Operations House of Representatives 97th Congress. In The Regulation of New Drugs by the Food and Drug Administration: The New Drug Review Process, 3-4 August. U.S.G.P.O., Washington, DC.
-
(1982)
The Regulation of New Drugs by the Food and Drug Administration: The New Drug Review Process
-
-
-
72
-
-
0010748298
-
Hearings of the intergovernmental relations and human resources subcommittee of the house of representatives 1983
-
26-27 April. U.S. Congress, Washington, DC
-
U.S. Congress (1983a) Hearings of the Intergovernmental Relations and Human Resources Subcommittee of the House of Representatives 1983. In FDA's Regulation of Zomax, 26-27 April. U.S. Congress, Washington, DC.
-
(1983)
FDA's Regulation of Zomax
-
-
-
73
-
-
0010702053
-
31st report, house committee on government operations
-
U.S.G.P.O, Washington, DC
-
U.S. Congress (1983b) 31st Report, House Committee on Government Operations. In FDA's Regulation of Zomax. U.S.G.P.O, Washington, DC.
-
(1983)
FDA's Regulation of Zomax
-
-
-
74
-
-
0010708456
-
Hearings before a subcommittee of the house committee on government operations
-
27 May. U.S. Congress, Washington, DC
-
U.S. Congress (1987) Hearings before a Subcommittee of the House Committee on Government Operations. In FDA's Regulation of the New Drug Suprol, 27 May. U.S. Congress, Washington, DC.
-
(1987)
FDA's Regulation of the New Drug Suprol
-
-
-
75
-
-
0010707979
-
Arthritis drug linked with cancer
-
22 June
-
Veitch, A. (1987) Arthritis drug linked with cancer. Guardian, 22 June, 5.
-
(1987)
Guardian
, pp. 5
-
-
Veitch, A.1
-
76
-
-
0026444040
-
The gap between legal rules and practice in advertising non-registered pharmaceutical products
-
Wieringa, N. F.et al. (1992) The gap between legal rules and practice in advertising non-registered pharmaceutical products. Social Science & Medicine 35, 1497-1504.
-
(1992)
Social Science & Medicine
, vol.35
, pp. 1497-1504
-
-
Wieringa, N.F.1
-
78
-
-
0016155029
-
Toxicological methods
-
Worden, A. N. (1974) Toxicological methods. Toxicology 2, 359-370.
-
(1974)
Toxicology
, vol.2
, pp. 359-370
-
-
Worden, A.N.1
|